Reporter Dai Yuxiang / Taipei Report
High-end Vaccine (6547) announced on the 12th that its EV71 vaccine has obtained domestic new drug inspection, registration and listing approval with complete third-phase clinical vaccine protection data. In addition to actively arranging production lines, it will also apply for drug certificates in target markets such as Southeast Asia as soon as possible, encouraging the opening of today (13) to jump the limit and the stock price reached 63 yuan.
Inspired by the bullish news, the high-end vaccines opened today with a gap and the daily limit, and the stock price reached 63 yuan. So far, 2,164 sheets have been traded, and more than 2,600 sheets have been commissioned. The group stock Ji Ya (3176) was offered at 34.75 yuan, and it once rose by more than 7% in early trading; Yunchen (2390) was opened at 13.25 yuan, and it also rose by more than 6% in early trading.
The high-end enterovirus 71 vaccine obtained the approval letter for new drug inspection and registration from the Food and Drug Administration on the 12th, which is the first enterovirus vaccine drug certificate approved by the non-accelerated approval mechanism (neutralizing antibody) in China. High-end said that the high-end EV71 vaccine has achieved 100% real-world vaccine protection in the third phase of multi-country and multi-center clinical trials. This data has been published by the world’s authoritative journal The Lancet. High-end is also currently the only developer in China that has its own production capacity for enterovirus vaccines.
EV71 is prevalent in hot and humid regions. Except for Taiwan, Southeast Asia and mainland China are localized EV71 endemic diseases. In terms of vaccine development, currently only 3 vaccine factories in mainland China have been listed, and 2 vaccine factories in Taiwan are preparing to launch products on the market.
High-end said that following obtaining the official drug certificate of the domestic enterovirus vaccine with complete data, it will continue to deploy in overseas markets. With the excellent effectiveness data of the third phase clinical trial and the approval of the drug certificate in Taiwan, it will spread to Southeast Asia and other countries where the EV71 epidemic is prevalent (such as: Vietnam, Thailand, Malaysia, etc.), as well as target countries with specific market layouts, submit drug license applications.
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